Orexigen Therapeutics said that Health Canada has accepted to review a New Drug Submission for marketing approval of products Contrave (naltrexone HCl and bupropion HCl).
The weight-loss products focused company said that the regulatory submission was filed by Valeant Canada, an affiliate of Valeant Pharmaceuticals International, Inc. If approved, Valeant will market and distribute Contrave in Canada as part of its distributorship agreement with Orexigen, executed in August 2016.
Dr. Thomas Cannell, Chief Operating Officer and President of Global Commercial Products of Orexigen, said: “We look forward to leveraging our strong alliance management capabilities to support Valeant’s commercialization in the Canadian market.”
According to the agreement, Valeant will be obtain regulatory approval and be responsible for all commercialization activity and expenses. Valeant aims to kick off with selling Contrave in the first half of 2018.
Orexigen said that, according to data from Statistics Canada, estimates of the economic burden of obesity in Canada range from $4.6 billion to $7.1 billion annually.
Orexigen has partnerships to commercialize Contrave and Mysimba (naltrexone HCl / bupropion HCl prolonged release) in a total of 39 countries worldwide, including partnerships with Valeant in Canada, Australia, New Zealand, South Africa and 21 European countries.